Treatment of Chronic Itch in Atopic Dermatitis (Eczema)

  • STATUS
    Recruiting
  • days left to enroll
    73
  • participants needed
    8
  • sponsor
    University of Minnesota
Updated on 10 September 2021

Summary

The purpose of this study is to assess the safety and efficacy of oral clonidine in subjects with symptomatic atopic dermatitis and to assess the safety and efficacy of oral naltrexone in subjects with symptomatic atopic dermatitis.

Description

This study will serve as a pilot study to determine the efficacy and safety of two novel oral agents (clonidine, naltrexone) in the treatment of chronic, non-experimentally induced itch in atopic dermatitis. In this study, eight subjects with symptomatic atopic dermatitis will be recruited and treated with either oral clonidine (four subjects) or oral naltrexone (four subjects) . Disease burden will be evaluated before and after 4 weeks of treatment through reporting of subjective symptomatology via surveys/questionnaire, neurometer study, and clinical assessment.

Details
Condition Cutaneous Nerves CNS Itch
Treatment naltrexone, clonidine
Clinical Study IdentifierNCT02268448
SponsorUniversity of Minnesota
Last Modified on10 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age range 18-70 years old and ability to give informed consent and HIPAA authorization
Female subjects of childbearing potential must have a negative pregnancy test, and must agree to practice two methods of effective birth control during the study period as clonidine is an FDA pregnancy category C drug (including abstinence, oral or implant contraceptives or condoms)
Diagnosis of AD via simplified UK Working Group Criteria and a baseline PSGA score of 2 or greater
Willingness to adhere to study protocol
Subjects taking hormone-containing medications must be on a stable dose for 6 months prior to study start to avoid any confounding influence on sensory and pain perception

Exclusion Criteria

Use of topical or oral anti-inflammatory medications for 2 weeks prior to the study start
Use of topical or oral anti-histamines for 2 weeks prior to the study start
Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start
Use of oral neuromodulatory agents for 2 months prior to study start
Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs)
Use of nicotine-containing products for the past 6 months prior to study start
History of radiation or chemotherapy
History of traumatic injury on prospective test sites
Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy (Duyff et al, 2000)
Known history of central or peripheral nervous system dysfunction
History of acute hepatitis, chronic liver disease or end stage liver disease
History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome
History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls
Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start
Use of illicit drugs within the past 6 months prior to study start
History of daily use of power tools
Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents
Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications
Adults lacking capacity to consent
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